Events

Recall of Device Recall Medtronic SynchroMed II implantable drug pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic, Inc. - Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57651
  • Event Risk Class
    Class 1
  • Event Number
    Z-1060-2011
  • Event Initiated Date
    2011-01-14
  • Event Date Posted
    2011-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96917
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    This letter provides important reminders concerning the potential for a pocket fill during a synchromed¿ ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum.
  • Action
    The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication. Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT. UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a

Device

Device Recall Medtronic SynchroMed II implantable drug pump
  • Model / Serial
    All units of these pump models are affected. Updates will be conducted on the Labeling, Training and Education Materials and the Refill Template which is included with the refill kits wil be redesigned.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, FAROE ISLANDS, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTI LES, NORWAY, PANAMA, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAN MARINO, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VATICAN CITY.
  • Product Description
    Medtronic SynchroMed II (Model No: 8637) implantable drug pump || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of preservative-free morphine sulfate sterile solution. " Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Preservative-free sterile saline, USP, can only be used to achieve the physician prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. " Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen injection). " Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.
  • Manufacturer
    Medtronic, Inc. - Neuromodulation

Manufacturer

Medtronic, Inc. - Neuromodulation
  • Manufacturer Address
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA